Download Multistate Outbreak Investigation of Fungal Meningitis

Information Sharing:
Outbreak of Fungal Infections
Associated with Contaminated
Steroid Injections
David H. Trump, MD, MPH, MPA
State Epidemiologist and Director, Office of Epidemiology
Virginia Department of Health
Session Objectives
• Specify the inter-related roles of local, state, and
federal public health agencies in response to largescale outbreaks of communicable diseases
• Explain the importance of coordination and
information sharing between the clinical community
and public health to characterize and respond
effectively to such outbreaks
• Describe how regional coordination and public
information play critical roles in support of an
organized, comprehensive response
Outline
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Tennessee meningitis patients
Methylprednisolone acetate traceback
Current case definition
Multistate outbreak summary
Virginia outbreak summary
Partnerships
Tennessee Meningitis Patients
• On 9/18, Tennessee Dept of Health was notified of 1
patient with Aspergillus meningitis who had been treated
at an ambulatory surgical center
• By 9/25, 7 more patients with meningitis had been
identified from the same ambulatory surgical center
• Symptoms included headache, stiff neck and fatigue; four
patients presented with strokes
• CSF cultures were negative
• On 9/27, North Carolina reported 1 patient with similar
clinical presentation
• All patients had received injections of preservative-free
methylprednisolone acetate (MPA)
What is methylprednisolone acetate
(MPA)?
• Corticosteroid hormone
• Used to treat pain and swelling
• Often administered to individuals with arthritis or
other joint disorders
• Mutes immune response
• Frequently injected into spinal
area
• In this case – preservative free
Source: AP
Methylprednisolone Acetate Traceback NECC
• Implicated product traced back to one compounding
pharmacy in Massachusetts
• Facility identified as New England Compounding Center
(NECC)
• 3 lots identified as being implicated
Source: AP
What is a compounding pharmacy?
• Can customize medications to fit a patient’s needs (“made from scratch”)
• Physicians often prescribe compounded pharmaceuticals when
manufactured drug won’t work (because of dose needed, drug delivery
system, allergies, drug shortages, etc.)
• Compounding can be performed at independent drug centers/labs,
hospitals, large chain drug stores and smaller independent pharmacies
• Regulated differently than non-compounding pharmacies
– Not directly/routinely regulated by the FDA
– Regulated primarily by State Boards of
Pharmacy
Source: Professional Compounding Centers of America
MPA Traceback
• On 10/3, NECC shut down operations
• On 10/4, CDC and FDA recommended all healthcare
professionals cease use and remove any product
produced by NECC
• On 10/4, FDA reported observing
fungal contamination from a sealed
vial from NECC
• On 10/6, NECC issued a recall of all
products that were produced at the
facility in Framingham, MA
Source: Reuters
MPA Traceback
• On 10/18, CDC and FDA confirmed the presence of
Exserohilum rostratum, a fungus, in unopened MPA
• On 10/26, FDA released an inspection report (483
report)
– Observed and confirmed
contaminated products at firm
– Observed problems with NECC’s
ability to maintain clean room
Source: http://www.cdc.gov/media/releases/2012/images/dpk-meningitisexserohilum2.jpg
Methylprednisolone Acetate Traceback
List of Healthcare Facilities that Received Lots of Methylprednisolone Acetate
(PF) Recalled from New England Compounding Center on September 26, 2012
Source: http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html
Current Case Definition - Meningitis and
Other Infections
Probable Case
•
A person who received a preservative-free methylprednisolone acetate (MPA) injection, with preservativefree MPA that definitely or likely came from one of the following three lots produced by the New England
Compounding Center (NECC) [05212012@68, 06292012@26, 08102012@51], and subsequently developed
any of the following:
– Meningitis1 of unknown etiology following epidural or paraspinal injection2 after May 21, 2012;
– Posterior circulation stroke without a cardioembolic source and without documentation of a normal
cerebrospinal fluid (CSF) profile, following epidural or paraspinal injection2 after May 21, 2012;3
– Osteomyelitis, abscess or other infection (e.g., soft tissue infection) of unknown etiology, in the spinal or
paraspinal structures at or near the site of injection following epidural or paraspinal injection2 after May
21, 2012; or
– Osteomyelitis or worsening inflammatory arthritis of a peripheral joint (e.g., knee, shoulder, or ankle) of
unknown etiology diagnosed following joint injection after May 21, 2012.
1 Clinically diagnosed meningitis with one or more of the following symptoms: headache, fever, stiff neck, or
photophobia, in addition to a CSF profile showing pleocytosis (>5 white blood cells, adjusting for presence of
red blood cells by subtracting 1 white blood cell for every 500 red blood cells present) regardless of glucose or
protein levels.
2 Paraspinal injections include, but are not limited to, spinal facet joint injection, sacroiliac joint injection, or
spinal or paraspinal nerve root/ganglion block.
3 Patients in this category who do not have any documented CSF results should have a lumbar puncture
performed if possible, using a different site than was used for the epidural injection when possible.
Confirmed Case
•
A probable case with evidence (by culture, histopathology, or molecular assay) of a fungal pathogen
associated with the clinical syndrome.
Last Revised October 24, 2012
Multistate Outbreak Summary
• 733 case-patients
from 20 states,
including VA
• 53 deaths
reported
• VA reported the
4th most cases
nationally
*data as of 4/8/2013
Source: http://www.cdc.gov/hai/outbreaks/meningitis-map.html
Multistate Outbreak Summary
*data as of 4/8/2013
Source: http://www.cdc.gov/hai/outbreaks/meningitis-map.html
Virginia Outbreak Summary
• Implicated lots of methylprednisolone acetate shipped to two facilities in
Virginia
– Insight Imaging, Roanoke VA (over 600 patients)
– New River Valley Surgery Center, Christiansburg VA (less than 30
patients)
• 675 patients received implicated product (from June 28, 2012 to
September 28, 2012)
– Exposed resided in 10 VA health districts and 4 other states
• 53 case-patients from these facilities reported as of April 23, 2013 (VA –
50, WV – 3)
• 41 cases with meningitis only;
• 8 cases with meningitis and spinal/paraspinal infection;
• 4 cases with spinal/paraspinal infection only
• 2 deaths reported as of April 23, 2013
Fungal Infections among Patients Exposed in Virginia
by Date of Initial Symptom Onset
(n= 52; missing= 1)
6
Number of Cases
5
4
3
2
1
0
Date of Initial Symptom Onset
Virginia Outbreak – Clinical Information
Symptom
n (%)
Headache
47 (89%)
Neck Stiffness
29 (55%)
Fever
27 (51%)
Nausea
20 (38%)
Back Pain
13 (25%)
Chills
12 (23%)
Photophobia
10 (19%)
Weakness/Numbness
9 (17%)
Vomiting
6 (11%)
Median Incubation Period (range)**
21.5 (1–100)
*data as of 4/23/2013
** n = 52
LHDs with Exposed Residents
= location of facility that received
potentially contaminated product
Federal, State, Local and Clinical
Partnerships
Federal
Clinical
State
Local